Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma

NCT ID: NCT00401817

Last Updated: 2017-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2013-11-30

Brief Summary

Primary Objective

1. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL).

Secondary Objectives

1. To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL.

2. To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.

Detailed Description

Bevacizumab administered at 15 mg/kg on day 1 of each of 6 cycles

Rituximab administered 375 mg/m2 on day 3 of each of 6 cycles (with usual premedications)

Standard CHOP chemotherapy administered on day 3 every 21 days (full dose) for 6 cycles of treatment

Once completed six cycles of therapy (~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.

Conditions

Untreated Mantle Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Treatment Arm

Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

15 mg/kg on day 1 of each of 6 cycles

Rituximab

Intervention Type: DRUG

Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles.

The dose to be administered is:

Rituximab: 375 mg/m2

CHOP

Intervention Type: DRUG

Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7

Interventions

Bevacizumab

15 mg/kg on day 1 of each of 6 cycles

Intervention Type: DRUG

Rituximab

Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles.

The dose to be administered is:

Rituximab: 375 mg/m2

Intervention Type: DRUG

CHOP

Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profile: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-)
• Patient has not received any prior anti-cancer therapy for lymphoma
• Laboratory parameters (unless considered by investigator to be due to lymphoma):

Absolute neutrophil count > 1000 cells/mm3 Platelet count > 50,000 cells/mm3 Hemoglobin > 7 gm/dL Creatinine < 2.0 x ULN Total bilirubin < 2.0 x ULN

• Patient has at least one tumor mass > 1.5 cm in one dimension
• Available tumor tissue for correlative studies (rebiopsy to be performed if needed)
• Patient is > 18 years old
• Patient has KPS > 50%
• Patient has signed IRB-approved informed consent
• Patient agrees to use birth control for duration of study

Exclusion Criteria

• Known central nervous system (CNS) involvement by lymphoma
• Known hepatitis infection
• Known HIV positivity
• Known history of renal disease with proteinuria; urine protein:creatinine ratio ³1.0 at screening
• Uncontrolled hypertension: blood pressure of >150/100 mmHg at screening
• Unstable angina
• History of myocardial infarction within 6 months
• History of stroke within 6 months
• Clinically significant peripheral vascular disease
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• Patient has ejection fraction < 50%
• Patient is taking coumadin, or has known history of thrombosis within last 6 months
• Evidence of bleeding diathesis or coagulopathy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study
• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
• Serious, non-healing wound, ulcer, or bone fracture
• Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• Patient is pregnant or nursing
• Patient is receiving other investigational drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John P Leonard, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Rush University Medical Center

Chicago, Illinois, United States

Weill Medical College of Cornell University

New York, New York, United States

Countries

United States

Other Identifiers

0604008463

Identifier Type: -

Identifier Source: org_study_id